Telfast Allergy 120 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Fexofenadine hydrochloride

Available from:

Opella Healthcare France SAS T/A Sanofi

ATC code:

R06AX; R06AX26

INN (International Name):

Fexofenadine hydrochloride

Dosage:

120 milligram(s)

Pharmaceutical form:

Film-coated tablet

Therapeutic area:

Other antihistamines for systemic use; fexofenadine

Authorization status:

Not marketed

Authorization date:

2013-03-01

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
TELFAST ALLERGY 120 MG FILM COATED TABLETS
Fexofenadine hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist has told
you.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if you need more information or advice.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
-
You must talk to a doctor if you do not feel better or if you feel
worse.
WHAT IS IN THIS LEAFLET:
1.
What Telfast Allergy is and what it is used for
2.
What you need to know before you take Telfast Allergy
3.
How to take Telfast Allergy
4.
Possible side effects
5.
How to store Telfast Allergy
6.
Contents of the pack and other information
1.
WHAT TELFAST ALLERGY IS AND WHAT IT IS USED FOR
Telfast Allergy 120 mg film-coated-tablets (called Telfast Allergy
throughout this leaflet) contains
fexofenadine hydrochloride, which is a non-drowsy antihistamine.
Telfast Allergy is used in adults and adolescents of 12 years and
older to relieve the symptoms that
occur with allergic rhinitis (for example hay fever), such as
sneezing, itchy, runny or blocked nose
and itchy, red and watery eyes.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TELFAST ALLERGY
DO NOT TAKE
Telfast Allergy

if you are allergic to fexofenadine or any of the other ingredients of
this medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Telfast Allergy if:

you have problems with your liver or kidneys

you have or ever had heart disease, since this kind of medicine may
lead to a fast or irregular
heart beat

you are elderly.
If any of these apply to you, or if you are not sure, tell your doctor
before taking Telfast Allergy.
OTHER MEDICINES AND TELFAST ALLERGY
Tell your doctor or pharmacist if you

Summary of Product characteristics

Health Products Regulatory Authority
26 March 2024
CRN00DWTL
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Telfast Allergy 120 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 120 mg of fexofenadine hydrochloride, which is
equivalent to 112 mg of fexofenadine.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Peach, modified capsule-shaped, film-coated tablet debossed with
‘012’ on one side and a scripted ‘e’ on the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Telfast Allergy 120 mg is indicated in adults and children 12 years
and older for the relief of symptoms associated with allergic
rhinitis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults _
The recommended dose of fexofenadine hydrochloride for adults is 120
mg once daily taken before a meal.
Fexofenadine is a pharmacologically active metabolite of terfenadine.
_PAEDIATRIC POPULATION_

Children aged 12 years and over
The recommended dose of fexofenadine hydrochloride for children aged
12 years and over is 120 mg once daily
taken before a meal.

Children under 12 years of age
The efficacy and safety of fexofenadine hydrochloride 120mg has not
been studied in children under 12.
In children from 6 to 11 years of age: fexofenadine hydrochloride 30
mg tablet is the appropriate formulation for
administration and dosing in this population.
_SPECIAL POPULATIONS_
Studies in special risk groups (older people, renally or hepatically
impaired patients) indicate that it is not necessary to adjust
the dose of fexofenadine hydrochloride in these patients
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
Health Products Regulatory Authority
26 March 2024
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Page 2 of 6
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
There is limited data in the elderly and renally or hepatically
impaired patients. Fexofenadine hydrochloride should be
administered with ca